510(k) · Cleared
ClearedVT Dressing Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carilex Medical, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Jun 8, 2018 as substantially equivalent to K112458 (Medica-Rents Co., Ltd., 2012) after a 270-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Jun 8, 2018
- Review
- 270 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945062 (1995). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 3 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 2 generations backK062456 Novaspine Powered Suction Pump Pro-1Novaspine, LLC · 2006
- 1 generation backK112458 Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy…Medica-Rents Co., Ltd. · 2012
- This deviceK172725 VT Dressing KitsCarilex Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK190119 Foryou NPWT Dressing Kit4l Health Co., Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190119Foryou NPWT Dressing Kit4l Health Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −3 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −2 | K062456 | Novaspine Powered Suction Pump Pro-1 | Novaspine, LLC | 2006 | — |
| −1 | K112458 | Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy System | Medica-Rents Co., Ltd. | 2012 | — |
| 0 (this device) | K172725 | VT Dressing Kits | Carilex Medical, Inc. | 2018 | — |
| +1 | K190119 | Foryou NPWT Dressing Kit | 4l Health Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OMP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OMP device
- #1 K260646 Renasys Edge (66803126)score 15.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112458 | Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy SystemSummary page 4…& Plastic Surgery 5. Predicate Device Information: DeRoyal Foam Kits w/DOME/TR of Prospera PRO-I, PRO-II and PRO-III Negative Pressure Wound Therapy System, K112458 6. Device Description Carilex VT Dressing Kits is the wound dressing to be used with the Carilex VT suction pumps fo… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190119 | Foryou NPWT Dressing Kit | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K190119 (4l Health Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K112458.
How does its category compare?
All OMP devicesOMP Negative Pressure Wound Therapy Powered Suction Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OMP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMP
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMP
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMP
140in 2025
MAUDE reports naming product code OMP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 113 | 0 | 1 |
| 2008 | 8 | 98 | 0 | 1 |
| 2009 | 8 | 87 | 7 | 79 |
| 2010 | 6 | 97 | 3 | 80 |
| 2011 | 6 | 123 | 0 | 130 |
| 2012 | 11 | 292 | 1 | 97 |
| 2013 | 11 | 84 | 2 | 169 |
| 2014 | 10 | 179 | 4 | 229 |
| 2015 | 20 | 189 | 1 | 378 |
| 2016 | 19 | 146 | 2 | 398 |
| 2017 | 11 | 137 | 0 | 368 |
| 2018 | 13 | 214 | 0 | 422 |
| 2019 | 15 | 249 | 1 | 994 |
| 2020 | 6 | 179 | 0 | 3,664 |
| 2021 | 9 | 238 | 0 | 1,422 |
| 2022 | 10 | 229 | 0 | 258 |
| 2023 | 8 | 291 | 0 | 143 |
| 2024 | 9 | 181 | 2 | 135 |
| 2025 | 5 | 127 | 0 | 140 |
| 2026 | 9 | 141 | 0 | — |
What is it indicated for?
Carilex VT Dressing Kits is intended to be used with the Carilex VT device (S1 series) to manage wounds through removal of fluids, and the NPWT system is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of fluids, excess exudates, infectious material, and tissue debris.
The Carilex VT Dressing Kits is indicated for use for patients with the following wounds:
- Traumatic
- Dehisced wounds
- Partial-thickness burns
- Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers
- Acute wounds
- Flaps and grafts
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172725: VT Dressing Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172725
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026